BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX MRI SURESCAN

    MDR report key: 3862469 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06884
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 30, 2014
    Manufacturer
    MPRI
    Product Code
    NVN
    PMA / PMN Number
    P090013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. PRODUCTS: (B)(4) LEAD IMPLANTED: 2013 (B)(6). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH WEAKNESS, POSITIVE BLOOD CULTURES, ENDOCARDITIS, AND VEGETATION WAS NOTED ON THE LEADS. THE RIGHT VENTRICULAR (RV) LEAD WAS ALSO REPORTED TO HAVE DIMINISHED R WAVES. THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS AND THE ENTIRE IMPLANTABLE PULSE GENERATOR (IPG) SYSTEM WAS REMOVED. THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339689 CAPSUREFIX MRI SURESCAN DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE NVN MPRI 5086MRI58

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R A3DR01 IPG